Anti-Diarrheal

Label at a glance#

Contacts and useful links#

PhoneLabel contact1-877-753-3935

PhoneLabel contact1-800-200-6313

Websitewww.myleader.comwww.myleader.com

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCI 2 mg

Purpose

OTC - PURPOSE SECTION

Anti-diarrheal

Use

INDICATIONS & USAGE SECTION

controls symptoms of diarrhea, including Travelers' Diarrhea

Warnings

WARNINGS SECTION

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl.

Heart alert: Taking more than directed can cause serious heart problems or death

Do not use

OTC - DO NOT USE SECTION

• if you have bloody or black stool
• in children under 12 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• fever
• mucus in the stool
• a history of liver disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking antibiotics.

When using this product

OTC - WHEN USING SECTION

tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• symptoms get worse
• diarrhea lasts for more than 2 days
• you get abdominal swelling or bulging. These may be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea
• not for use in children under 12 years of age
• adults and children 12 years of age and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Other information

OTHER SAFETY INFORMATION

• store at 20º-25ºC (68º-77ºF), Protect from light.
• avoid excessive heat above 40°C (104°F)
• do not use if carton or blister unit is open or torn
• see side panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil and purified water

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Loperamide Hydrochloride

Capsules, 2 mg

Anti-Diarrheal

Controls The Symptoms Of Diarrhea

Suitable for adults and children 12 years and over

SOFTGELS*

*(Liquid-filled Capsules)

COMPARE TO IMODIUM® A-D active ingredient**

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

**This product is not manufactured or distributed by Johnson & Johnson Consumer, Inc., distributor of Imodium® A-D.

DISTRIBUTED BY CARDINAL HEALTH

DUNLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Billing Units#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

• Anti-Diarrheal
• Loperamide HCl
• LOPERAMIDE HYDROCHLORIDE
• LOPERAMIDE
• BUTYLATED HYDROXYANISOLE
• FD&C BLUE NO. 1
• GELATIN
• GLYCERIN
• GLYCERYL MONOCAPRYLATE
• POLYOXYL 40 HYDROGENATED CASTOR OIL
• WATER

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.